FDA-Device2013-04-24Class II
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Nipro Diagnostics, Inc.
Hazard
Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
Sold states
Nationwide Distribution only in NY.
Affected count
1,627 Kits
Manufactured in
2400 NW 55th Ct, N/A, Ft Lauderdale, FL, United States
Products
Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1140-2013Don't want to check this manually?
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